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The Ventway Sparrow ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg ( 1 1b.), who require the following types of ventilatory support: SIMV VC PS, SIMV PC PS or CPAP.

The Ventway Sparrow lung ventilator is intended for emergency use and during transportation. It may be used for invasive (via an endotracheal tube and tracheostomy) or noninvasive (full non-vented ventilation face mask) ventilation presets. It may be used in hospital (transport) and field environments.

Models VWSP100MR and VWSP900MR may be used in a Magnetic Resonance (MR) environment up to 3 Tesla.

The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.

The Ventway Sparrow ventilator (a.k.a. Ventway Ventilator / Ventway System) is a portable ventilator, used for transport, in prehospital, field hospital, and hospital settings.

The ventilator is suitable for non-invasive ventilation for a full non-vented ventilation face mask or for invasive ventilation via an endotracheal tube or tracheostomy.

The Ventway is available in 2 models plus MR conditional use:

• . VWSP-100 Civil Model
• VWSP-100MR Civil Model ●
• VWSP-900 Robust Model ●
• VWSP-900MR Robust Model

The Ventway Sparrow consists of a ventilator unit with an LCD screen and a single use patient circuit.

The document provided is a 510(k) Premarket Notification from the FDA regarding the "Ventway Sparrow" ventilator. It is a regulatory document and does not contain a study that proves the device meets specific acceptance criteria.

Instead, it details the device's indications for use, technological characteristics, and non-clinical testing performed to establish substantial equivalence to a predicate device (LTV® 1200 MR Conditional Ventilator).

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from this document. The document primarily focuses on demonstrating that the Ventway Sparrow is "substantially equivalent" to an already cleared device, K083688, based on similar intended use and technological characteristics, and that it has undergone various non-clinical performance and safety tests.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, number of experts, qualifications of experts, or adjudication methods for a ground truth test set.
• A multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• A standalone algorithm performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any specific performance claims.
• Sample size for a training set or how ground truth for a training set was established.

The "Performance" section within Table 1 lists various ventilatory modes and settings, but these are descriptions of the device's capabilities, not acceptance criteria for a study demonstrating performance. The non-clinical testing listed primarily covers safety, electrical, environmental, and engineering standards compliance.

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